Submission Details
| 510(k) Number | K171037 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 06, 2017 |
| Decision Date | December 27, 2017 |
| Days to Decision | 265 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
Cleared
Traditional
PoreStar Patient Specific Implant
Dec 2017
Decision
265d
Days
Class 2
Risk
About This 510(k) Submission
K171037 is an FDA 510(k) clearance for the PoreStar Patient Specific Implant, a Polymer, Ent Synthetic, Porous Polyethylene (Class II — Special Controls, product code JOF), submitted by Anatomics Pty, Ltd. (St Kilda, AU). The FDA issued a Cleared decision on December 27, 2017, 265 days after receiving the submission on April 6, 2017. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3620.
Device Classification
| Product Code | JOF — Polymer, Ent Synthetic, Porous Polyethylene |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 874.3620 |
Manufacturer
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